Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324506
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2006-05-09
Brief Title:
Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Randomized Open-label Parallel-Group Multicenter Study to Determine the SafetyEfficacy of Mycophenolate Mofetil in Mono Combination Therapy With Interferon Beta 1a in Patients With Relapsing Remitting Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this safetymechanistic study is to determine the safety and tolerability of oral Cellcept when compared with weekly intramuscular Avonex in relapsing multiple sclerosis Safety will be assessed by virtue of changes in size and number of lesions on MRI scans
Detailed Description:
Sixty patients 20 patients at each recruiting center with RR MS who satisfy both inclusion and exclusion criteria will be treated with CellCept or Avonex for the first 6 months of the study Those patients will have a fifty-fifty chance of receiving either Avonex or Cellcept Baseline data will be collected before treatment begins including MRIs chest x-ray EKG and standard labwork along with a blood test for HIV and Hepatitis B Once enrolled study visits include periodic MRI scans a neurological exam by the examining neurologist every three months frequent bloodwork questionnaires and eye-testing at month zero six and twelve months Eye testing takes about one hour and requires dilation of pupils All assessments are standard of care for ophthalmology with the exception of optical coherence tomography OCT-- a non-invasive procedural device that records graphical and numerical measurements of the optic nerve and macula
All patients will begin active combination therapy on both CellCept and Avonex during the second 6 months of the study During this second phase MRI and clinical examinations will be performed
All patients will begin active combination therapy on both CellCept and Avonex during the second 6 months of the study During this second phase MRI and clinical examinations will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB 012006-028 | None | None | None |